Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia

Technology

Arm/hand function

Online since 28 August 2023, updated 323 days ago

About this trial

This trial is enrolling individuals with chronic, incomplete, cervical spinal cord injuries to test the effect of a home-based, telehealth-supported intervention combining Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) Exercise and Transspinal Stimulation (TS) on arm and hand function. TS is a technique for stimulating the spinal cord via surface electrodes to modify spinal cord function. Participants will first undergo baseline measurements at the laboratory for 2 weeks. Then they will undergo 2 weeks of training at home to become familiar with the telehealth platform. Participants will then undergo 3 sessions/week for 16 weeks of either: 1) BES + active TS; or 2) BES + sham (inactive) TS at home with telehealth supervision. Final testing will be performed after 30 weeks.

Included participants

Gender

All

Age

18 - 70 years

Injury level

C1 - C8

Severity (AIS)?

AIS-B

AIS-C

AIS-D

Time since injury

≥ 1 year

Injury type

Traumatic

Healthy volunteers

C1-C8

Additionally, participants must

Have visible muscle contraction in response to neuromuscular electrical stimulation of the wrist extensor muscles

Have a companion that can assist the participant with research activities throughout the study

Possess appropriate technology to enable telehealth participation in the trial (web camera, computer, microphone, speakers, high-speed broadband internet connection, telephone number)

What’s involved

Type

Technology

Details

1) Participants will undergo baseline measurements at the laboratory for 4 weeks 2) Participants will undergo 2 educational sessions/week to familiarize with the TS and telehealth platform at home 3) Participants will then undergo 16 weeks of 3 sessions/week of either i) BES + active TS or ii) BES + sham TS at home with telehealth supervision 4) Final testing will be performed 20 weeks after baseline testing--total length of participation is 30 weeks

Potential benefits

Main benefits

Arm/hand function

Additional benefits

General health

Sensory function

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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